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FDA 510(k)

SUSI II PACEMAKER SURVEILLANCE MONITOR

K-Number: K792602 · 1980-03-25

ApplicantEla Medical, Inc.
Decision Date1980-03-25
Product CodeDTC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUSI II PACEMAKER SURVEILLANCE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Ela Medical, Inc.. It received FDA 510(k) clearance on 1980-03-25 under 510(k) number K792602. The device is classified under product code DTC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUSI II PACEMAKER SURVEILLANCE MONITOR?

SUSI II PACEMAKER SURVEILLANCE MONITOR is a medical device that received FDA 510(k) clearance on 1980-03-25. The listed applicant is Ela Medical, Inc.. The 510(k) number is K792602.

When did SUSI II PACEMAKER SURVEILLANCE MONITOR receive FDA 510(k) clearance?

SUSI II PACEMAKER SURVEILLANCE MONITOR received FDA 510(k) clearance on 1980-03-25, under 510(k) number K792602.

Who is the listed applicant for SUSI II PACEMAKER SURVEILLANCE MONITOR?

The FDA 510(k) record lists Ela Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUSI II PACEMAKER SURVEILLANCE MONITOR?

The FDA product code for SUSI II PACEMAKER SURVEILLANCE MONITOR is DTC.

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Other records listing Ela Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042002SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADERK032466SPIDERVIEWK002817SYNETECK993448STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK000029STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADSK990727SYNEFLASH & SYNEVIEW

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Related Devices (Code: DTC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170815PSA CableBoston Scientific CorporationK083674PK-141 PATIENT CABLEBiotronik, Inc.K011729SIGMA PACE EXTERNAL PACEMAKER ANALYZER MODEL #1000Dni Nevada, Inc.K002497MODEL 4810 ANALYZER OUTPUT ADAPTERPace MedicalK961582EXTERNAL PACEMAKER ANALYZER, MODEL PMT 100North American Technical Services Corp.K903966EXTERNAL PACEMAKER ANALYZER MODEL PMA-1Bio-Tek Instruments, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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